This is a prospective, single-arm, open-label Phase 1 dose-finding and expansion study to evaluate the safety, tolerability, pharmacokinetics, and anti-tumor efficacy profiles of the cell-based LCAR-C18S (hereinafter "LCAR-C18S") in subjects with Claudin18.2-positive advanced solid Tumors.
This is a prospective, single-arm, open-label Phase 1 dose-finding and expansion study to evaluate the safety, tolerability, pharmacokinetics, and anti-tumor efficacy profiles of the cell-based LCAR-C18S (hereinafter "LCAR-C18S") in subjects with Claudin18.2-positive advanced solid Tumors. Patients who meet the eligibility criteria will receive LCAR-C18S infusion. The study will include the following sequential phases: screening, pre-treatment , treatment and follow up
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
34
Before treatment with LCAR-C18S cells, subjects will receive a conditioning regimen
Anhui Provincial Hospital
Hefei, Anhui, China
Shanghai East Hospital
Shanghai, China/Shanghai, China
Shanghai Artemed Hospital
Shanghai, Shanghai Municipality, China
Dose-limiting toxicity (DLT) and incidence, severity, and type of treatment-emergent adverse events (TEAEs),Safety
Dose-limiting toxicity (DLT) and incidence, severity, and type of treatment-emergent adverse events (TEAEs),Safety
Time frame: Minimum 2 years after LCAR-C18S infusion (Day 1)
To determine the recommended dose of the phase Ⅱ trial of this cell therapy (RP2D)
To determine the recommended dose of the phase Ⅱ trial of this cell therapy (RP2D)
Time frame: 90 days post infusion
Pharmacokinetic (PK) parameters
Blood samples will be collected for determination of cellular concentrations and transgenic levels of serum LCAR-C18S for pharmacokinetic analysis
Time frame: Minimum 2 years after LCAR-C18S infusion (Day 1)
Overall response rate (ORR) after administration
Objective Response Rate (ORR) is defined as the proportion of subjects who achieve CR or PR after treatment via LCAR-C18S cell infusion, and the objective tumor response rate will be calculated for patients with measurable disease per RECIST 1.1 only
Time frame: Minimum 2 years after LCAR-C18S infusion (Day 1)
Progress Free Survival (PFS) after administration
Progression Free Survival (PFS) is defined as the time from the date of first infusion of the LCAR-C18S to the first documented disease progression (according to RECIST 1.1) or death (due to any cause), whichever occurs first
Time frame: Minimum 2 years after LCAR-C18S infusion (Day 1)
Overall Survival (OS) after administration
Overall Survival (OS) is defined as the time from the date of first infusion of LCAR-C18S to death of the subject.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: Minimum 2 years after LCAR-C18S infusion (Day 1)